Direct Enzymatic HbA1c
Request package insert information
MSDS
MSDS - Controls and Callibrators
Brochure
Product Features
Diazyme’s NSGP Certified Direct Enzymatic HbA1c assay is the only HbA1c assay that has no interference from hemoglobin variants including HbC, HbS, HbE, and caramylated acetylated Hb or labile HbA1c. This unique freedom from interference combined with unparalleled precision (intra and inter % CV values less than 2.6%) means that Diazyme’s Direct Enzymatic HbA1c assay provides unique performance advantages over conventional immunoassay and chromatography methods.  Diazyme’s patented enzymatic method measures HbA1c directly using only a single instrument channel and completely eliminates the latex particles cuvette contamination often seen in HbA1c immunoassay methods. This reduces instrument maintenance requirements.   Diazyme’s Direct HbA1c and can be used on most automated chemistry analyzers and reagent transfer can be eliminated for most chemistry systems with instrument specific packaging options including Roche Hitachi 917 series, Olympus AU (400/600/640/680), Beckman Synchron CX, LX and DXC. The assay correlates well with conventional methods such as the Tosoh™ HPLC and Roche™ Tina-Quant methods and has linear range of 4%-16%. The assay is stable for 12 months when stored @ 2°-8°C.
Assay Principle
Whole blood samples are lysed with a lysing buffer and the released hemoglobin molecules are digested with a protease mix. This process releases amino acids including glycated valines from the hemoglobin beta chains. Glycated valines then serve as substrates for specific recombinant fructosyl valine oxidase (FVO) enzyme which specifically cleaves N-terminal valines and produces hydrogen peroxide in the presence of selective agents. This, in turn, is measured using a horseradish peroxidase (POD) catalyzed reaction and a suitable chromagen. The HbA1c concentration is expressed directly as %HbA1c by use of a suitable calibration curve in which the calibrators have values for each level in %HbA1c.
Intended use
For the quantitative in vitro determination of glycated hemoglobin (%HbA1c) in human blood. HbA1c is a long term (2 - 3 months) indicator of diabetic control.
Product Catalog Number Packaging Method/Format
Kit (90 Tests) DZ168A-K R1a: 1 x 16.8 mL;
R1b: 1 x 7.2 mL
R2: 1 x 10 mL;
Lysis Buffer: 1 x 30 mL		 Enzymatic, endpoint
Liquid Stable
Calibrator DZ168A-Cal 2 x 0.5 mL  
Control DZ168A-Con 2 x 0.5 mL